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Evaluation of Immune Status Before and After Splenectomy in Immune Thrombocytopenia Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03998059
Recruitment Status : Recruiting
First Posted : June 25, 2019
Last Update Posted : August 27, 2021
Sponsor:
Information provided by (Responsible Party):
Zhang Lei, Institute of Hematology & Blood Diseases Hospital

Study Description
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Brief Summary:
Evaluation of immune status before and after splenectomy in immune thrombocytopenia patients.

Condition or disease Intervention/treatment
Thrombocytopenia Splenectomy Procedure: splenectomy

Detailed Description:

A total of 30 ITP patients will be enrolled in the study. These patients should fail to have sustained response to multiple first- and second-line treatments of ITP and agree to have splenectomy. Before splenectomy, these patients will be reassessed and still diagnosed with ITP.Their platelet level will be raised to a safe state before surgery, and the laparoscopic splenectomy will be performed in Tianjin People's Hospital. The investigators plan to take 20ml of peripheral blood (PB) of these patients at 6 time points, including 1 day before surgery, 1 week, 1 month, 3 months, 6 months, and 12 months after surgery, and take a small amount of spleen tissue during surgery.

18 age- and gender- matched healthy donor will also be enrolled as controls and taken 20ml of peripheral blood. The investigators also plan to take splenic tissue from 10 patients who have splenectomy due to Hereditary spherocytosis or trauma.

And then the investigators will do the experiments step by step. 1, Isolation of peripheral blood and splenic mononuclear cells;2, Detection of the percentage of cell population;3, Activation and proliferation of B lymphocyte; 4, Activation and proliferation of T lymphocyte;5,Apoptosis of platelets by cytotoxic T cells;6,Phagocytosis of platelets by macrophages in spleen;7,Enzyme-linked immunosorbent assay (ELISA) for cytokines.

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of Immune Status Before and After Splenectomy in Immune Thrombocytopenia Patients
Actual Study Start Date : January 23, 2019
Estimated Primary Completion Date : January 23, 2022
Estimated Study Completion Date : July 23, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
30 immune thrombocytopenia(ITP) patients
A total of 30 cases. The investigators plan to take 20ml of peripheral blood (PB) of these 30 ITP patients at 6 time points, including 1 day before surgery, 1 week, 1 month, 3 months, 6 months, and 12 months after surgery
 Procedure: splenectomy
These patients should fail to have sustained response to multiple first- and second-line treatments of ITP and agree to have splenectomy.Before splenectomy, these patients will be reassessed and still diagnosed with ITP.Their platelet level will be raised to a safe state before surgery, and the laparoscopic splenectomy will be performed in Tianjin People's Hospital.
20 normal controls
A total of 20 cases.18 age- and gender- matched healthy donor will also be enrolled as controls and taken 20ml of peripheral blood.
Spleens of the 30 cases patients(ITP)
These 30 ITP patients agree to have splenectomy.The investigators will take a small amount of spleen tissue during surgery.
Spleens of the 10 cases patients(normal controls)
The investigators also plan to take splenic tissue from 10 patients who have splenectomy due to hereditary spherocytosis or trauma.


Outcome Measures
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Primary Outcome Measures :
  1. Changes of the percentage of cell population [ Time Frame: 1 year ]
    To assess the changes of the percentage of B cell subsets，regulatory B cells（Breg），regulatory T cells (Treg)，supressor T cells（Ts），monocyte Fc receptor（FCR）I/II, FCRIII and FCRIIb, helper T cells（Th）subsets and the functionally-polarized CD4+ T cell subsets in peripheral blood mononuclear cells（PBMCs）at 6 time points, including 1 day before surgery, 1 week, 1 month, 3 months, 6 months, and 12 months after surgery, and to compare with the healthy controls.

  2. Changes of activation and proliferation of B and T lymphocyte, apoptosis of platelets by cytotoxic T cells(CTLs) [ Time Frame: 1 year ]
    To assess the changes of activation and proliferation of B and T lymphocyte, apoptosis of platelets by cytotoxic T cells(CTLs) in peripheral blood mononuclear cells（PBMCs）at 6 time points, including 1 day before surgery, 1 week, 1 month, 3 months, 6 months, and 12 months after surgery, and to compare with the healthy controls.

  3. Changes of cytokines in the cell culture supernatants and plasma [ Time Frame: 1 year ]
    To assess the changes of cytokines in the cell culture supernatants and plasma at 6 time points, including 1 day before surgery, 1 week, 1 month, 3 months, 6 months, and 12 months after surgery, and to compare with the healthy controls.


Secondary Outcome Measures :
  1. Changes of phagocytosis of platelets by macrophages in itp patients spleen and the normal spleen controls. [ Time Frame: The day of the splenectomy ]
    To assess the changes of phagocytosis of platelets by macrophages in itp patients spleen and the normal spleen controls.

  2. Changes of the percentage of cell population, activation and proliferation of B and T lymphocyte, apoptosis of platelets by cytotoxic T cells(CTLs) in itp patients spleen and the normal spleen controls. [ Time Frame: The day of the splenectomy ]
    To assess the changes of the percentage of B cell subsets，regulatory B cells（Breg），regulatory T cells (Treg)，supressor T cells（Ts），monocyte Fc receptor（FCR）I/II, FCRIII and FCRIIb, helper T cells（Th）subsets ,the functionally-polarized CD4+ T cell subsets, activation and proliferation of B and T lymphocyte, apoptosis of platelets by cytotoxic T cells(CTLs) in itp patients spleen and the normal spleen controls.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The ITP patients who are eligible for inclusion, but not eligible for exclusion, will be included in the clinical trials.
Criteria

Inclusion Criteria:

  • Aged 18 to 60 years old, male or female;
  • Conform to the diagnostic criteria of immune Thrombocytopenia (ITP)
  • Needed splenectomy;
  • People who are willing to sign the informed consent voluntarily and follow the research program.

Exclusion Criteria:

  • Secondary thrombocytopenic purpura;
  • Patients with poor compliance;
  • Researchers believe that patients should not participate in the test of any other condition.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03998059


Contacts
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Contact: Yunfei Chen, MD +86-22-23909009 chenyunfei@ihcams.ac.cn
Contact: Lei Zhang, MD +86-22-23909240 zhanglei1@ihcams.ac.cn

Locations
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China, Tianjin
Yunfei Chen Recruiting
Tianjin, Tianjin, China, 300020
Contact: Yunfei Chen, Doctor    +86-22-23909009    chenyunfei@ihcams.ac.cn   
Sponsors and Collaborators
Zhang Lei
Investigators
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Principal Investigator: Lei Zhang, MD Chinese Academy of Medical Science and Blood Disease Hospital
More Information
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Publications:

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Responsible Party: Zhang Lei, vice Director of Thrombosis and Hemostasis Center, Institute of Hematology & Blood Diseases Hospital
ClinicalTrials.gov Identifier: NCT03998059    
Other Study ID Numbers: KT2018087-EC-1
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: August 27, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhang Lei, Institute of Hematology & Blood Diseases Hospital:
Thrombocytopenia
splenectomy
Additional relevant MeSH terms:
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Thrombocytopenia
Immune System Diseases
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Purpura
 Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations